Phase II Study of AS1411 Combined With Cytarabine to Treat Acute Myeloid Leukemia

Leukemia, Myeloid Clinical Trial

Official title:

An Open Label Randomized Controlled Dose Escalating Phase II Study of AS1411 Combined With Cytarabine in the Treatment of Patients With Primary Refractory or Relapsed Acute Myeloid Leukemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00512083
• Other study ID #: AS1411-C-201
• Status: Completed
• Phase: Phase 2
• First received: August 6, 2007
• Last updated: September 24, 2009
• Start date: July 2007

Study information

• Verified date: September 2009
• Source: Antisoma Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The overall aim of this study is to assess the efficacy and safety of AS1411, over a range of doses, when combined with cytarabine, in the treatment of patients with primary refractory or relapsed acute myeloid leukemia (AML).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• primary refractory or relapsed AML

• confirmed diagnosis of AML (de novo or secondary) as defined by WHO classification (Vardiman 2002)

• aged at least 18 years

Exclusion Criteria:

• initial diagnosis of acute promyelocytic leukemia as defined by French-American-British criteria (Bennett 1976)

• patient in blast crisis stage of chronic myeloid leukemia

• received high-dose cytarabine (total cumulative dose of >6g/m sq)in last 6 months

• interval of <6 months between first onset of last complete remission and current relapse

• those with primary refractory leukemia who have received more than three previous induction cycles

• relapsed patients who have received more than three previous treatment regimens

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

Drug:
• AS1411
AS1411 IV administration continuously over 7 days. Dose either 10mg/kg/day or 40 mg/kg/day.

Locations

Country	Name	City	State
New Zealand	Christchurch Hospital	Christchurch
United States	Univeristy of Colorado Health Cancer Center	Aurora	Colorado
United States	St. Francis Hospital and Health Center	Beech Grove	Indiana
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Duke University Medical Center	Durham	North Carolina
United States	UCLA Medical Center	Los Angeles	California
United States	University of Louisville, James Graham Brown Cancer Center	Louisville	Kentucky
United States	University of Nebraska Medical Center	Omaha	Nebraska
United States	Cancer Therapy and Research Center - Institute for Drug development	San Antonio	Texas
United States	Washington University	St Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Antisoma Research

Countries where clinical trial is conducted

United States,  New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The prorportion of patients achieving a completel response (CR) after the first cycle of treatment in each treatment group			No